Regulatory/Legislative Comments

The American Cleaning Institute laid out a detailed work plan on additional safety and efficacy data for the three major ingredients used in consumer antibacterial soaps that aligns with requests from the Food and Drug Administration. Additionally, the document submitted to FDA says ACI and its members are planning to work over the coming years to generate safety and effectiveness data to support a total of six active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, isopropyl alcohol and povidone iodine) across four FDA OTC topical antimicrobial monographs (Consumer Hand Wash products, Consumer Hand Rub products, Food Handler Products and Health Care Products). Read ACI’s full comments here.

October 2015

The American Cleaning Institute (ACI) urged the Food and Drug Administration to re-evaluate all data relevant to the safety and efficacy of antibacterial health care ingredients and make affirmative findings that they are generally recognized as safe and effective. ACI submitted detailed comments October 28, 2015 to FDA concering the agency’s proposed rules governing over-the-counter antiseptic healthcare products. Read ACI’s full comments here.

June 2014

Triclosan Plays "Beneficial Role" for "Millions of People", FDA Told - The Food and Drug Administration will find that there is sufficient information available "demonstrating the safety and efficacy" of triclosan, according to the American Cleaning Institute. In formal comments submitted to the Agency June 16, 2014, ACI said that triclosan-containing antibacterial wash products "play a beneficial role in the daily hygiene routines of millions of people throughout the U.S. and worldwide. They have been and are used safely and effectively in homes, hospitals, schools and workplaces every single day." Read ACI’s full comments here.

Antibacterial Ingredient Chloroxylenol: "Long History of Safe Use" - Soaps containing the antibacterial ingredient chloroxylenol have a long track record of human and environmental safety which is supported by science-based, transparent risk analyses. In comments to the Food and Drug Administration submitted June 16, 2014, the American Cleaning Institute said the Agency did not appropriately assess the safety data that are available prior to proposing that additional data are necessary to support the use of chloroxylenol in consumer antibacterial washes. ACI’s complete comments can be access here.

The Facts on Antibacterial Products and Antibiotic Resistance

September 2011

Research published in the International Journal of Microbiology Research reaffirms that the use of antibacterial wash products in the home environment does not contribute to antibiotic or antibacterial resistance, confirming previous research that showcased similar findings. You can find the research online here. A news release summarizing the findings is available here.

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October 2005

This issue brief was presented to the Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee meeting by SDA and CTFA on October 20, 2005. The paper summarizes research demonstrating there is no real world evidence linking the use of topical antimicrobial products to antibiotic resistance.

Research published in the Centers for Disease Control and Prevention (CDC) journal Emerging Infectious Diseases (October 2005) finds that the use of antibacterial cleaning products does not lead to a "significant increase in antimicrobial drug resistance after one year, nor did it have an effect on bacterial susceptibility to triclosan." You can find the research paper online at http://www.cdc.gov/ncidod/EID/vol11no10/04-1276.htm.

An independent study published in the October 2004 Journal of Applied Microbiology reports finding "negative correlations" between biocide usage and antibiotic resistance. The study was funded by SDA and The Cosmetic, Toiletry, and Fragrance Association.

Data from a separate SDA-contracted study were statistically analyzed by British researcher Dr. Ronald W. Lambert to look for correlations among specific groups of clinical bacterial isolates with regard to their susceptibilities to clinically relevant antibiotics and common antimicrobials.

The results of this study indicated that increases in the antibiotic resistance of strains of Staphylococcus and Pseudomonas were not caused by increases in their biocide resistance.

"From the analyses of these clinical isolates it is very difficult to support a hypothesis that increased biocide resistance is a cause of increased antibiotic resistance either in Staph. aureus or in Ps. Aeruginosa," the author stated.

"The observation of negative correlations between antibiotics and biocides may be a useful reason for the continued use of biocides promoting hygiene in the hospital environment," he concluded.

The risks of antibacterial resistance developing from the use of antibacterial cleaning products may well have been overstated and that health and hygiene are being compromised as a result. That's the conclusion of an article published in the May 2004 issue of Microbiology Today by University of Manchester (UK) researchers Peter Gilbert and Andrew McBain.

Professors' McBain and Gilbert also presented research at the 104th General Meeting of the American Society for Microbiology (ASM) in New Orleans in May 2004. That research, according to an ASM news release, shows that "the risk of bacteria developing antibiotic resistance after exposure to the biocide triclosan may not be as great as previously believed."

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April 2004

Research Shows No Association Between Triclosan Usage, Antibiotic Resistance

A scientific review on the use of triclosan (a common ingredient in antibacterial soap) -- published in the April 2004 Journal of Antimicrobial Chemotherapy – stated that "comprehensive environmental surveys have not demonstrated any association between triclosan usage and antibiotic resistance."

A study in October 2003 Journal of Applied Microbiology "refutes widely publicized, yet unsupported, hypotheses that use of antibacterial products facilitates the development of antibiotic resistance in bacteria from the home environment."

The use of topical antimicrobial wash products does not contribute to antimicrobial resistance, according to the latest comprehensive scientific literature provided to the Food and Drug Administration (FDA).

"Based on the totality of the data, there is no compelling evidence suggesting that triclosan usage has contributed towards the development of resistance to triclosan or triclosan-antibiotic cross-resistance in the clinical setting or the home environment."

F urther, the paper states that "current levels of triclosan usage in cosmetic products are considered safe, and based on available data, not expected to select for antimicrobial resistant bacteria."

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June/September 2002

In June 2002, a European Commission Scientific Steering Committee completed a comprehensive and thorough scientific review and analysis of data on antibiotic resistance regarding triclosan, the most commonly used antibacterial ingredient in consumer products.

The panel reported that "There is no convincing evidence that triclosan poses a risk to humans or to the environment by inducing or transmitting antibacterial resistance under current conditions of use."

On September 17, 2002, the European Commission’s Scientific Committee on Cosmetic Products and Non-food Products Intended for Consumers (SCCNFP) endorsed the Scientific Steering Committee’s findings and recommendations.

Benefits of Antibacterial Soaps and Washes

April 2014

Newly published research shows that the use of antibacterial soaps can reduce the spread of harmful bacteria – that often leads to foodborne illness – more effectively than using non-antibacterial soaps. The research, published in the peer-reviewed Journal of Food Protection (Vol. 77, No. 4, 2014, pp. 574-582), used new laboratory data, together with simulation techniques, to compare the ability of non-antibacterial and antibacterial products to reduce the risk of the infectious disease shigellosis, which is often spread during food preparation. A link to the full research article (via PDF) is available here. A news release summarizing the research is available here.

November 2011

Handwashing with antibacterial soap produces statistically greater reductions in bacteria on the skin when compared to using non-antibacterial soap. Those are the findings of a review of two dozen relevant published studies – analyzing the effectiveness of antibacterial soaps – featured in the November 2011 edition of the peer-reviewed Journal of Food Protection.

A link to the research abstract is available here. Read a news release summarizing the study here.

October 2005

Benefits of Topical OTC Antimicrobial Products

This issue brief was presented to the Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee meeting by SDA and CTFA on October 20, 2005. The paper summarizes research describing the benefits of over-the-counter topical antimicrobial products, including bars, liquids, gels and wipes.

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October 2005

Endorsements for Consumer Topical Antimicrobial Products

This document was presented to the Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee meeting by SDA and CTFA on October 20, 2005. This summary describes examples of official regulations, guidelines or recommendations for the use of topical antimicrobial products in general population (non-healthcare) settings or situations.

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Study: Antimicrobials most effective in removing bacteria

March 2005

A study published in the American Journal of Infection Control (March 2005) found antimicrobial soap ingredients to be the "most efficacious" in removing bacteria from hands.

A comprehensive review of scientific research and literature is overwhelmingly supportive of the benefits of topical antimicrobial products in interrupting infection in invasive situations, interrupting disease transmission to oneself and others in non-invasive situations, as well as reducing the numbers of bacteria on the surface of the skin.

Much of this information has been transmitted to the U.S. Food and Drug Administration by a coalition consisting of The Soap and Detergent Association and The Cosmetic, Toiletry, and Fragrance Association.

Part of the Coalition’s August 2001 submission to the FDA showcased benefits in home, institutional and clinical settings